With its share price halved just a year after listing, directly taking the brunt of a biotech chill, GC Genome has made a bold move with a bid to "preempt the U.S. pancreatic cancer diagnostics market." With a signal of structural improvement from turning an operating profit in the first quarter, attention is on whether it will post a full-fledged turnaround in earnings in the second half.
GC Genome's closing price fell more than 56%, from 11,100 won on the first day of listing on June 11 last year to 4,850 won on the 19th. Analysts in the securities industry say overall investor sentiment toward biotech stocks has weakened and profitability has not yet met expectations.
GC Genome's first-quarter revenue this year was 7.4 billion won, up 9% from the same period last year. Operating profit was 140 million won. It swung to the black from an operating loss of 250 billion won in the first quarter of last year. Ha Tae-gi, an analyst at Sangsangin Investment & Securities, said, "There is a seasonal pattern in which revenue concentrates in the second half."
GC Genome is a subsidiary of GC Biopharma, and its main business is Genifit. Genifit analyzes fetal DNA in a pregnant woman's blood to assess the likelihood of chromosomal abnormalities such as Down syndrome in the fetus. A safer test is possible regardless of the mother's age. The company said demand is rising as the number of births has recently increased.
i-CANcer detect, which uses artificial intelligence (AI) to screen early for colorectal, gastric, lung and other cancers, is also growing. With a single blood draw, it predicts the likelihood that 10 types of cancer are present. It requires 10 mL of blood, and the test takes about 7 to 14 days. The company says the turnaround time is shorter and the required blood volume is smaller than competitors.
i-CANcer detect's client sites increased to 51 last year from 35 in 2024. It aims to expand to about 160 client sites by the end of this year. It has been introduced for health checkups for Samsung Group employees and in Kangbuk Samsung Hospital's lifetime health program. The company also said it is signing contracts with other corporations.
The company is seeking to enter the U.S. with Pan-cancer detect, which screens for pancreatic cancer early. The United States is considered a high-potential market, with more than 100 million people eligible for cancer screening. The number of high-risk pancreatic cancer patients is also steadily increasing.
GC Genome plans to complete clinical trials for Pan-cancer detect by this year and, as early as year-end, apply to the U.S. Food and Drug Administration (FDA) for breakthrough device designation. If designated as a breakthrough device, the product can be launched in the United States. The company is targeting approval as early as next year and commercialization in 2028.
The company said, "To preempt the U.S. market, we plan to launch a single-cancer screening product," adding, "Single-cancer screening allows easier accumulation of clinical data and faster insurance coverage, but multi-cancer early screening requires extensive data, making initial entry difficult."